11

A New Paradigm for Medical Products Regulation in Taiwan

Taiwan Food and Drug Administration 2010.09.10

2 22

TFDA Organization Chart

2

3 33

Pharmaceuticals Regulation in Taiwan

3

Post-Market Management

Quality

Drug InjuryRelief

Research & Discovery

PreclinicalTesting

NDA/PMA

GLP

ADR/AE ★ Reporting

Insurance

cGMP

Market

GPvP

ADR/AE Reporting

IRB/GCP

IND/IDE

Pre-Market Approval

GTP

★ADR/AE: adverse drug reaction/adverse event

4

1980 1990 2000 2010

1982GMP

1999cGMP

2010PIC/S GMP

1993Local

clinical trial

2000Bridging Study

Evaluation in accordance with

ICH E5

2001Pivotal trial/

early phase trial

1998CDE

2001TDRF

2010TFDA

Milestones on Drug Regulation

5

Establishment of TFDA and Reform of Drug Review System

Enhancing quality, efficiency, and transparency in reviewing of pharmaceuticals and medical devices

Fostering the development of biopharmaceutical industry

Promoting international harmonization on drug regulation

5

6

Transparency and Quality Assurance

Review quality assurance: QA/QC task force (2010.03)

On-line Roadmap : for tracking review progress for sponsor (2010.05)

Implementation of Good Review Practice (GRP) (2010.07)

Disclosure of assessment report for NCE (2010.08)

6

7 77

NDA/PMA Review ProcessSponsor Application

Technical and administrative document,

GMP/PMF

TFDA Review Team (TFDA Staff+ CDE)

Assessment report

Consult with AC experts for special concern Advisory

Committee

Sponsor

Decision

7

Global New,Botanical product,

Biosimilar product, etc.

8 8

Establishment of modern Clinical Trial Environment in Taiwan

Preclinical GLP inspection Meet international standard

GCP inspection Follow ICH –E6 GCP

Enhancement of the quality of IRB international: SIDCER or FERCAP certified IRB domestic : DOH audited 38 IRB

Training for clinical trial professional Investigators, clinical research coordinators (CRC), clinical research

associates (CRA), study nurses etc. Improvement of clinical trial Infrastructure

8

9 99

Improvement of Clinical Trial Infrastructure

Government funded Research CentersGrant $22 million (NT) in 2010General Clinical Research Center (GCRC): 11 sites Center of Excellence: 5 sitesCenter of Excellence for Cancer Research: 8 sitesSite Management Organization (SMO)

Qualified sites for IND/IDE: 128 teaching hospitals

9

10

MOU ★ between Taiwan Center of Excellence and International Pharmaceutical Company

MOU assigning date Taiwan-international pharmaceutical company

2007-09-30 National Taiwan University-GSK

2009-03-25 National Taiwan University-Novartis

2009-07-16 National Taiwan University-Boehringer Ingelheim

2009-11-30 National Taiwan University-Pfizer

2010-05-13 Taipei Veterans General Hospital-GSK

2010-08-31 Chung Gung Medical Hospital-Novartis

2010-09-01 China Medical University Hospital -Novartis

10★MOU: Memorandum of Understanding

11

Taiwan Global Trials Sponsored by International Companies

source: 2007~2010 Q2, CDE database

Ranking　 International Company Case number (phase I-III)

1 A 49

2 B 35

3 C 31

4 D 26

5 E 26

6 F 21

7 G 21

8 H 19

9 I 19

10 J 17

11 Roche 1512 L 1511

12 12

Clinical trials conducted in Asia as of July 12, 2010

East Asia South Asia Southeast Asia

Taiwan 1792 India 1331 Singapore 692

Japan 1523 Pakistan 150 Thailand 717

Korea Republic of 1907 Bangladesh 76 Philippines 393

China 1664 Nepal 13 Malaysia 326

HongKong 519 Sri Lanka 14 Indonesia 116

Korea, Democratic People’s Republic of

0 Afghanistan 7 Cambodia 15

Vietnam 70

Myanmar 4

Total 7,405 Total 1,591 Total 2,333

Source: http://www.clinicaltrials.gov

13

Clinical Trial Environment in Excellent Centers

Country Taiwan Korea China

Population 22.9 M 48 M 1300 M

Cost Approval of

Protocol

1~1.5 Months

2~3 Months

8~12 Months

Investigator (US trained) Data Quality Medical staff

Patient retention

13

source: TrialTrove, May 2009

14 1414

International Cooperation Memorandum of Understanding with Australia EOLs ★ : GMP inspection & AE information sharing with USA, EU,

and Switzerland TCP ★ ISO 13485 audit report sharing with 12 EU Notified Bodies Application of PIC/S membership APEC (LSIF, ISTWG), ICH-GCG and etc. Future works:

Promote collaboration with Japan, China and Korea, Singapore and Thailand

Participate WHO and related organization or meetings, such as ICDRAs ★

1414

★EOLs: exchange of letters

★ ICDRAs: International Conference of Drug Regulatory Authorities

★TCP:Technical Cooperation Program

15

Cross-Strait Cooperation in Clinical Trial

ECFA ★, Signed Between China and Taiwan (2010.06), opens a favorable cross-strait interaction mechanism and will improve the basis of promoting Taiwan’s cooperation with other countries

Cross-Strait cooperation on new drug research and clinical trial (in progress)

★ECFA: Economic Cooperation Framework Agreement

1616

16

Non-CPP 1-CPP 2-CPP

Major Breakthroughs (I)Relaxation of CPP

1. pivotal clinical trial

in Taiwan

2. REMS/RMP if necessary

1. Early phase

clinical trials

in Taiwan

2. REMS/RMP

1. REMS/RMP if necessary

Expected review time720 days ( 2 years):

360days plus GXP inspection 360days

Expected review time300 days

Expected review time200 days

★CPP: Certificate for Pharmaceutical Product from 10 advanced countries ★REMS/RMP: Risk Evaluation and Mitigation Strategy/ Risk management plan★ GXP: GCP,GLP,GMP

1717

Accelerated Review

(For new agents with high

industrial value)

Abbreviated Review

(FDA + EMA approved)

Verification Review(Future with MOU) Priority Review

(unmet medical needs)

Priority review:Full documents

Partial review,focused on bridging data, REMS, PSUR, etc.

Verification based on reference agencies’assessment reports

Major Breakthroughs (II)New Review Tracks

Accelerated Review:Full documents

Expected review time ： 180 days

Expected reviewtime:150 days

Expected review time： 180 days

18

Major Breakthroughs (III) CTN Scheme

Multi-national clinical trials approved by advanced country

One of Taiwan’s medical centers participated

Refer to Australian CTN scheme to accelerate the protocol review process

Implement since Aug 18, 2010

★CTN: Clinical Trial Notification

19

Major Breakthroughs (IV) Biopark Cooperation

To plan the TFDA campus and establish the Biotech Industry Consultation and Education Resource Center in Nangang National Biotechnology Research Park

20

Future Prospect

20

To create friendly regulatory environment

To promote excellent R&D infrastructure for innovative medical products

Quality Efficiency

International Harmonization Transparency

21

Taiwan:Centrally Located in East Asia

Tokyo 2’50

Seoul 2’20

Manila 2’00

Osaka 2’15

Sydney 8’50

Taiwan

Beijing 3’00Beijing 3’00

Chongqing 3’00Chongqing 3’00

Shanghai 1’20Shanghai 1’20

Guangzhou 1’30Guangzhou 1’30

Hong Kong 1’40Hong Kong 1’40

Bangkok 3’45Bangkok 3’45

Ho Chi Minh City 3’20Ho Chi Minh City 3’20

Kuala Lumpur 4’35Kuala Lumpur 4’35

Singapore 4’20Singapore 4’20

Jakarta 5’00Jakarta 5’00

2222

Thank You for Your Attention

22